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Completed

NCT Number: NCT01663688

Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.

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Key information

Conditions

Ocular Physiology

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology, La Jolla, California, United States

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About this study

This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal and healthy male and female subjects at least 20 years of age.

Exclusion criteria

  • Subjects who have extensive or debilitating systemic diseases.
  • Subjects who have significant ocular disease.
  • Subjects who are extremely far sighted or extremely near sighted.

Treatment and study plan

Primary outcomes

  1. Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis

    Time frame: Subjects will be followed for the duration of the procedure, up to one day.

    The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.

Secondary outcomes

  1. Evaluation of adverse events found during the clinical study

    Time frame: Subjects will be followed for the duration of the procedure, up to one day.

    The secondary objective is to evaluate any adverse events found during the clinical study.

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2012
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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